Viewing data from:

FLOVENT HFA

NDA

FLUTICASONE PROPIONATE | N021433 | GLAXO GROUP LTD DBA GLAXOSMITHKLINE

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

417 trials from ClinicalTrials.gov — 1 recruiting, 4 active, 354 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Seal, Stopping Eczema and Allergy Study NCT03742414	Phase 2	Active	Kari Nadeau, MD, PhD	398	2021-06-30 → 2028-06-30
A Bronchoscopy Study to Assess the Effects of Inhaled Corticosteroids on Adult Healthy Volunteers NCT02476825	Phase 4	Active	University Hospitals, Leicester	30	2016-01-20 → 2026-10-31
The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype NCT04171167	N/A	Active	Tampere University Hospital	88	2017-04-04 → 2026-12
Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics NCT03002389	Phase 2	Active	University of Virginia	95	2017-11-05 → 2028-01-31
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma NCT01225913	Phase 4	Recruiting	Gelb, Arthur F., M.D.	50	2007-10 → 2027-06
Evaluating the Control of COPD Symptoms in Patients Treated With Tiotropium Bromide 18mcg Once Daily Alone, ADOAIR 50/250mcg Twice Daily Alone or ADOAIR 50/250mcg Plus Tiotropium Bromide 18mcg NCT01762800	Phase 4	Completed	GlaxoSmithKline	407	2013-02 → 2015-09
Assessment of Fluticasone Propionate on Ocular Allergy Symptoms NCT01817790	Phase 3	Completed	GlaxoSmithKline	626	2012-12 → 2013-02
Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block NCT02466503	Phase 1	Completed	Intech Biopharm Ltd.	45	2014-08 → 2014-09
Effects of Broccoli Sprout Extract on Allergy Rhinitis NCT02885025	Phase 2	Completed	VA Office of Research and Development	47	2016-10-01 → 2019-03-12
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler NCT02980133	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	841	2016-12-28 → 2019-04-13

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$21.58

per gm

Lowest NADAC/Unit

$11.73

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66993008096FLUTICASONE PROPIONATE HFA 220 MCG INHALER	$21.58	GM	Generic	—	2026-06-17
66993007996FLUTICASONE PROPIONATE HFA 110 MCG INHALER	$13.51	GM	Generic	—	2026-06-17
66993007896FLUTICASONE PROPIONATE HFA 44 MCG INHALER	$11.73	GM	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$85.76

Highest Price

$273.68

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66993-0078-96FLUTICASONE PROPIONATE 44MCG/SPRAY AEROSOL,IN	$131.62	FSS	Prasco, LLC	06/30/2026
66993-0078-96FLUTICASONE PROPIONATE 44MCG/SPRAY AEROSOL,IN	$85.76	Big4	Prasco, LLC	06/30/2026
66993-0079-96FLUTICASONE PROPIONATE 110MCG/SPRAY AEROSOL	$176.20	FSS	Prasco, LLC	06/30/2026
66993-0079-96FLUTICASONE PROPIONATE 110MCG/SPRAY AEROSOL	$114.79	Big4	Prasco, LLC	06/30/2026
66993-0080-96FLUTICASONE PROPIONATE 220MCG/SPRAY AEROSOL	$273.68	FSS	Prasco, LLC	06/30/2026
66993-0080-96FLUTICASONE PROPIONATE 220MCG/SPRAY AEROSOL	$176.61	Big4	Prasco, LLC	06/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Flovent HFA (2024)

Total Spending

$9.0M

Total Claims

27,166

Beneficiaries

20,884

Avg Cost/Unit

$25.94

Spending Trend

$423.0M(2019)→$463.1M(2020)→$464.9M(2021)→$445.1M(2022)→$394.5M(2023)→$9.0M(2024)

YoY Change:-3.8%

5yr CAGR:+1.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain28 active DMFs5 inactive

24 active API suppliers hold Drug Master Files for this ingredient.

WAVELENGTH ENTERPRISES LTDFLUTICASONE PROPIONATE

DMF 154562001

TAPI NL BVFLUTICASONE PROPIONATE

DMF 157452001

CIPLA LTDFLUTICASONE PROPIONATE USP

DMF 157742001

HOVIONE FARMACIENCIA SAFLUTICASONE PROPIONATE

DMF 163342002

STERLING SPAFLUTICASONE PROPIONATE

DMF 164232003

TARO PHARMACEUTICAL INDUSTRIES LTDFLUTICASONE PROPIONATE, MICRONIZED

DMF 176182004

AURISCO PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE USP

DMF 202122007

FARMABIOS SPAFLUTICASONE PROPIONATE USP/PH.EUR. (MICRONIZED)

DMF 204632007

CORAL DRUGS PVT LTDFLUTICASONE PROPIONATE

DMF 218792008

NEWCHEM SPAFLUTICASONE PROPIONATE MICRONIZED

DMF 222362008

AARTI PHARMALABS LTDFLUTICASONE PROPIONATE USP

DMF 229802009

INDUSTRIALE CHIMICA SRLFLUTICASONE PROPIONATE USP

DMF 234272010

HOVIONE FARMACIENCIA SAFLUTICASONE PROPIONATE INHALATION GRADE

DMF 247912011

AMPHASTAR NANJING PHARMACEUTICALS INCFLUTICASONE PROPIONATE, USP

DMF 294542015

LUPIN LTDFLUTICASONE PROPIONATE USP

DMF 299752015

CIPLA LTDFLUTICASONE PROPIONATE USP (PROCESS II)

DMF 304172016

GLAXOSMITHKLINEFLUTICASONE PROPIONATE

DMF 315342017

CHONGQING HUAPONT PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE INTERMEDIATE

DMF 327832018

GLAXOSMITHKLINE LLCFLUTICASONE PROPIONATE

DMF 329522018

CIPLA LTDFLUTICASONE PROPIONATE USP (PROCESS III)

DMF 331722018

TIANJIN TIANYAO PHARMACEUTICALS CO LTDFLUTICASONE PROPIONATE USP

DMF 341262019

AURISCO PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE (CRUDE)

DMF 342732019

SHANDONG SIRUI PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE

DMF 353592021

APOTEX INCFLUTICASONE PROPIONATE USP (MICRONIZED)

DMF 353932020

CORAL DRUGS PRIVATE LTDFLUTICASONE PROPIONATE (PROCESS 1)

DMF 363152021

CURIA SPAIN SAUFLUTICASONE PROPIONATE MICRONIZED

DMF 372972022

BREATHGREEN PHARMACEUTICAL CO LTDFLUTICASONE PROPIONATE(MICRONIZED AND NON-MICRONIZED)

DMF 387592023

VAMSI LABS LTDFLUTICASONE PROPIONATE USP

DMF 428122025

SCINOPHARM TAIWAN LTDInactiveFLUTICASONE PROPIONATE

DMF 156862001

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveFLUTICASONE PROPIONATE EP/BP

DMF 175442004

NEULAND LABORATORIES LTDInactiveFLUTICASONE PROPIONATE PH.EUR

DMF 191152006

MYLAN LABORATORIES LTDInactiveFLUTICASONE PROPIONATE USP

DMF 282642014

VAMSI LABS LTDInactiveFLUTICASONE PROPIONATE EP

DMF 402852024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Aug 19, 2021	SUPPL -40	View Letter (PDF)
Feb 13, 2019	SUPPL -34	View Letter (PDF)
Jul 21, 2017	SUPPL -33	View Letter (PDF)
Oct 6, 2016	SUPPL -32	View Letter (PDF)
Aug 1, 2016	SUPPL -31	View Letter (PDF)
Dec 12, 2014	SUPPL -26	View Letter (PDF)
Dec 3, 2014	SUPPL -19	View Letter (PDF)
Nov 17, 2014	SUPPL -25	View Letter (PDF)
Jul 22, 2013	SUPPL -22	View Letter (PDF)
Nov 8, 2010	SUPPL -15	View Letter (PDF)
Jul 2, 2008	SUPPL -11	View Letter (PDF)
Oct 27, 2006	SUPPL -6	View Letter (PDF)
Mar 3, 2006	SUPPL -4	View Letter (PDF)
Jan 18, 2006	SUPPL -5	View Letter (PDF)
May 26, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.22MG/INH

RLD

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: May 14, 2004

No patent or exclusivity listings for this strength.

#002 — 0.11MG/INH

RLD

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: May 14, 2004

#003 — 0.044MG/INH

RLDAB

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: May 14, 2004